Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT02871934
Description: Mortality and adverse event data collected non-systematically due to minimal risk nature of the trial intervention. Most mortality events discovered when attempting to reach patient for end-of-study survey. Any participant death or adverse event discovered by study staff during the observation period or via attempts to make contact for end-of-study survey (per protocol, contacts occurred up to 3 months after end of 12-month observation period) data collection are reported.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02871934
Study Brief: Integrating Pharmacogenetics In Clinical Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PGx+ Patients in the PGx+ (intervention) arm will have their SLCO1B1 results reported to their ordering provider immediately. SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C. 8 None 0 193 0 193 View
PGx- Patient in the PGx- (control) arm will have their SLCO1B1 results reported to their ordering provider at the end of the study (after 12 months). SLCO1B1 Genotype: Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C. 5 None 0 215 0 215 View
Serious Events(If Any):
Other Events(If Any):